AdvaMed Urges Passage of FDA User Fee Reauthorization

David Nexon, AdvaMed senior executive vice president, testified before members of the Senate Health, Education, Labor, and Pensions (HELP) Committee on behalf of the medical device and diagnostics industry. The Association believes the user fee agreement recently reached between the agency and the medical technology industry is a potential game-changer that could help accelerate the development and approval of safe and effective treatments and diagnostics.

“We urge the Committee and the Congress as a whole to act promptly to reauthorize the user fee program and enact this agreement into law,” Nexon said.

“Our industry has been a true American success story for patients and for the U.S. economy. America’s medical technology industry truly leads the world – but our leadership is slipping. One key reason – perhaps the most important reason – is the significant decline we have seen in FDA efficiency and consistency in recent years,” said Nexon.

The user fee agreement’s combination of groundbreaking accountability and transparency measures and enhanced FDA resources has the potential to increase the predictability, consistency and efficiency of FDA’s decision-making, while maintaining the agency’s stringent product approval standards. “Put simply, the agreement is good for FDA; it is good for industry; and most of all, it is good for American patients,” said Nexon.

The device industry is appreciative of efforts by several Members of Congress who have introduced legislative proposals to give FDA the tools and structure it needs to succeed. “Legislative reforms that do not alter the substance of the negotiated agreement between FDA and industry and seek to improve consistency and predictability in the FDA device review process hold the potential to create a legislative reauthorization package that maximizes the opportunity for success at the agency,” he stated, “which should be the shared goal of all involved.”